NCT07438769

Brief Summary

Persistent burn scar pain is common after blast and drone-related injuries and may be driven by scar fibrosis, vascular activity, and peripheral nerve involvement within scar tissue. This prospective cohort study aims to determine whether early ultrasound features of scars and nerves predict persistent clinically significant scar pain at 3 and 6 months. Ultrasound measures include scar thickness, echogenicity, Power Doppler vascularity, dynamic adhesion (gliding) assessment, and ultrasound signs of nerve involvement ("US-nerve positive"). Clinical outcomes include pain intensity (NRS), neuropathic pain screening (DN4), and functional interference.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

March 24, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

February 22, 2026

Last Update Submit

February 22, 2026

Conditions

Keywords

Burn scar painultrasoundnerve entrapmentblast injurydrone injuryneuropathic painchronic pain prediction

Outcome Measures

Primary Outcomes (1)

  • Persistent clinically significant scar pain

    Persistent scar pain defined as Numeric Rating Scale (NRS) ≥4 during movement or on light touch at follow-up assessment. The primary endpoint is the presence of clinically significant pain at 3 months after enrollment.

    3 mounth

Secondary Outcomes (1)

  • Persistent Clinically Significant Scar Pain at 6 Months

    6 mounth

Study Arms (2)

Persistent Scar Pain

articipants who develop clinically significant persistent scar pain defined as NRS ≥4 during movement or light touch at 3 or 6 months follow-up after burn injury.

No Persistent Scar Pain

Participants without clinically significant persistent scar pain (NRS \<4 during movement and light touch) at 3 and 6 months follow-up.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of adult patients (≥18 years) with clinically formed burn scars following blast-related, drone-related, or comparable burn injuries. Participants will be enrolled between 2 and 12 weeks after injury and followed prospectively for 6 months. Scars may be located on extremities, chest wall, or neck. The study population represents individuals at risk of developing persistent scar pain after combat-related or high-energy burn trauma.

You may qualify if:

  • Age ≥18 years
  • Burn injury with clinically formed scar
  • Enrollment 2-12 weeks after injury
  • Scar located on extremities, chest wall, or neck
  • Ability to provide written informed consent

You may not qualify if:

  • Severe cognitive impairment preventing valid questionnaires
  • Hemodynamic instability or inability to complete baseline evaluation
  • Active systemic infection (enrollment deferred until stable)
  • Pre-existing chronic pain condition unrelated to burn scar that would confound outcomes (investigator judgment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vinnitsya Regional Clinical Hospital n.a Pirogov

Vinnitsya, Select, 21018, Ukraine

Location

Related Links

MeSH Terms

Conditions

NeuralgiaNerve Compression SyndromesBlast Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBarotraumaWounds and Injuries

Central Study Contacts

Dmytro Dmytriiev, PhD.Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 22, 2026

First Posted

February 27, 2026

Study Start

March 24, 2026

Primary Completion

May 23, 2026

Study Completion

May 23, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations